US9655861B2ActiveUtilityA1

Oral pharmaceutical dosage forms

90
Assignee: DURECT CORPPriority: Dec 6, 2007Filed: Jul 13, 2015Granted: May 23, 2017
Est. expiryDec 6, 2027(~1.4 yrs left)· nominal 20-yr term from priority
A61P 35/00A61P 43/00A61P 25/36A61P 25/24A61P 25/00A61P 25/26A61P 29/00A61P 25/04A61P 25/20A61K 31/4402A61K 31/137A61K 31/4458A61K 9/4866A61K 31/485A61K 9/48A61P 19/02A61K 9/4858A61P 19/00
90
PatentIndex Score
6
Cited by
602
References
16
Claims

Abstract

Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Claims

exact text as granted — not AI-modified
We claim: 
     
       1. A composition comprising a mixture comprising:
 a methylphenidate or pharmaceutically acceptable salt thereof; 
 sucrose acetate isobutyrate (SAIB); 
 a cellulose acetate butyrate (CAB); 
 hydroxyethylcellulose (HEC); 
 about 0.01 wt % to about 5 wt % of a saturated polyglycolized glyceride (SPG); and 
 a solvent; 
 
       wherein the mixture is encapsulated within a capsule. 
     
     
       2. The composition of  claim 1 , wherein the methylphenidate or a pharmacologically acceptable salt thereof is present in an amount ranging from about 1.3 wt % to about 35 wt %. 
     
     
       3. The composition of  claim 1 , wherein the SAIB is present in an amount ranging from about 30 wt % to about 60 wt %. 
     
     
       4. The composition of  claim 1 , wherein the CAB has a number average molecular weight ranging from about 66,000 to about 83,000. 
     
     
       5. The composition of  claim 1 , wherein the CAB is present in an amount ranging from about 0.1 wt % to about 20 wt %. 
     
     
       6. The composition of  claim 1 , wherein the solvent is present in an amount ranging from about 0.1 wt % to about 40 wt %. 
     
     
       7. The composition of  claim 1 , wherein the mixture further comprises a rheology modifier. 
     
     
       8. The composition of  claim 1 , wherein the rheology modifier is present in an amount ranging from about 0.1 wt % to about 20 wt %. 
     
     
       9. The composition of  claim 1 , wherein the mixture further comprises a 6 silicon dioxide. 
     
     
       10. The composition of  claim 1 , wherein the mixture comprises methylphenidate. 
     
     
       11. The composition of  claim 1 , wherein the mixture comprises a pharmacologically acceptable salt of methylphenidate. 
     
     
       12. The composition of  claim 1 , wherein the mixture further comprises a rheology modifier selected from isopropyl myristate (IPM), caprylic/capric triglyceride, ethyl oleate, triethyl citrate, dimethyl phthalate, and benzyl benzoate. 
     
     
       13. The composition of  claim 1 , wherein the capsule comprises gelatin, hydroxyethylcellulose, or hydroxypropylmethylcellulose. 
     
     
       14. A pharmaceutical dosage form comprising the composition of  claim 1 . 
     
     
       15. The composition of  claim 1 , wherein the solvent is selected from triacetin, N-methyl-2-pyrrolidone, 2-pyrrolidone, dimethylsulfoxide, ethyl lactate, propylene carbonate, and gycofurol. 
     
     
       16. The composition of  claim 1 , wherein the solvent comprises triacetin.

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